COVID-19 Convalescent Plasma Collection: ABHH
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
03 31 2020
COVID-19 Convalescent Plasma Collection:
Donor Eligibility, Processing, Labeling, and Distribution
THIS PROTOCOL IS EXPECTED TO CHANGE AS FDA RELEASES NEW INFORMATION IN RESPONSE TO THE EVOLVING PANDEMIC. CHECK
FREQUENTLY FOR UPDATES.
This COVID-19 Convalescent Plasma (CCP) collection protocol was prepared by AABB based on information provided by
members of the CCP Collection Working Group, in consultation with the FDA’s Center for Biologics Evaluation and
Research. The Convalescent Plasma Collection Overview (Attachment A) and Convalescent Plasma Implementation
Checklist (Form 1) supplement the protocol.
This document is intended to serve as an FDA reviewed protocol that will help ensure CCP collections:
• Are rapidly available under an acceptable set of collection, manufacturing, and distribution practices.
• Are well-coordinated locally and nationally to promote an adequate inventory and expanded access to FDA
approved patient treatment.
• Meet FDA and AABB criteria required for:
o allogeneic blood donations, including consent, donor safety, and product safety, purity and potency.
o eventual administration to a patient under an FDA approved IND.
• Are distributed only to hospitals for use under an approved IND or a single patient emergency IND.
• Are collected and labeled as a licensed* FFP or PF24 blood component:
o to expedite CCP availability for treatment protocols by utilizing the existing component preparation
processes of licensed establishments, which represents the majority of collection establishments.
o with attributes for antibodies to COVID-19 and the cautionary statement for administration under IND
only.
o tie tags may be used for the cautionary statement and the receiving hospital’s IND number.
o OR use the alternative to label the collection as apheresis convalescent plasma using the appropriate
ICCBBA code.
*Registered (not licensed) establishments will determine the steps required for labeling and distribution of CCP
collections, including the same attributes and cautions.
CCP requires an FDA approved IND for administration to a patient but does not require an IND for collection,
manufacturing, and distribution. [Refer to FDA’s March 24th Communication]
This protocol is acceptable for use by AABB-accredited blood collection facilities. Facilities not accredited by AABB
should consider alignment with AABB Standards to ensure consistency in CCP collections. AABB may issue additional
requirements, including data collection requirements, for blood collectors providing CCP to hospitals for administration
under approved INDs.
Before collecting CCP, blood collection establishments should consider the following:
Preparation for a CCP collection program
• Develop SOPs for CCP collection and component preparation based on the information provided in this
document and compliance with FDA regulations and AABB Standards. Identify compliance strategies necessary
for CCP collections.
• Train staff on new SOPs, highlighting requirements that CCP collections meet all requirements for allogeneic
donations, as well as additional requirements which are unique to CCP, such as documentation of testing for
initial infection and recovery from infection (well and healthy on the day of donation), inventory management to
easily identify CCP units, segregation in storage, shipping and labeling requirements, and distribution limited to
hospitals with an approved IND.
• Provide education to staff describing the unique properties of CCP and the patients needing treatment with CCP.
Page 1 of 603 31 2020
• Discuss donor and staff safety and address concerns, providing information necessary to understand that CCP
donors are allogenic donors who are no longer ill and have tested negative for COVID-19 before arriving at the
donor center, whenever possible.
• Prepare the Blood Establishment Computer System and labeling processes:
o Select ICCBBA codes according to your collection process.
o Identify special attributes and required cautionary statement.
o Define limitations and criteria for distribution.
• Ensure recordkeeping procedures capture CCP donor eligibility and collection information, as required for all
allogeneic blood donors.
Donor Recruitment
Blood collection establishments should establish a donor recruitment plan for recovered COVID-19 donors suitable to
local conditions to ensure the donor eligibility criteria are met and collections are adequate for use with approved
patient treatment nationally.
Coordinate with the available local resources:
• Contact the public health departments, local hospitals, and health care providers that have treated COVID-19
patients to develop a partnership to recruit recovered patients as volunteer CCP donors.
• Develop appropriate process and messaging whereby treating clinicians and public health employees reach out
to recovered patients already discharged from care and newly recovered patients as they are discharged from
care.
• Encourage local partners to provide recovered patients with “hard copy” documentation for both the patient’s
initial positive diagnostic test AND a negative test for SARS-CoV-2 at the time of recovery. This documentation
must be provided to the blood collection establishment and may be hand carried. Refer to donor eligibility.
• Contact local media to deliver public service announcements requesting recovered COVID-19 patients contact
blood collection establishments.
Donor Eligibility Criteria and Documentation – refer to FDA’s March 24th Communication, unless otherwise noted:
• Documentation of SARS-CoV-2 infection (diagnosis and recovery) as follows:
o Prior diagnosis of COVID-19 by a laboratory test must be provided to the blood collection establishment
prior to collection. Written documentation is required and may be hand carried by the potential donor.
o Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a
molecular diagnostic test from blood [if less than 28 days have elapsed since the donor’s last
symptom(s).] A partial list of available tests can be accessed at https://www.fda.gov/medical-
devices/emergency-situations-medical-devices/emergency-use-authorizations.
• Potential CCP donors who have been symptom free for 28 days or longer are eligible as allogeneic donors under
the precautionary measures in the FDA’s March 11th communication, with documentation of prior diagnosis but
do not require the negative test to confirm recovery from infection. Donor recovery from COVID-19 prior to
donation based on testing and resolution of symptoms is necessary for:
o the safety of other donors and staff
o as evidence that the potential donor is healthy and well on the day of donation, as required by donor
eligibility criteria [if less than 28 days have elapsed since the donor’s last symptom(s).] FDA’s March 11th
considerations do not include a negative test for COVID-19 for such a donor if collected 28 days after the
last symptom. However, a facility may elect to apply more stringent criteria at any time.
• Donors must be male or females who are nulliparous or negative for HLA antibodies. This TRALI risk mitigation
strategy is consistent with AABB Standards for AABB accredited blood collectors.
• The CCP donor must meet all allogeneic blood donor eligibility criteria on the day of donation.
Page 2 of 603 31 2020
• The CCP donor may donate plasma once every 28 days as permitted by allogeneic donor eligibility criteria. Each
medical director must determine when more frequent plasma donations are appropriate and set a policy to
support both donor safety and the availability of CCP.
Donor Collection – refer to FDA’s March 24th Communication, unless otherwise noted:
Prior to donation, donor consent must be obtained (e.g. the AABB Donor History Questionnaire).
• Additionally, consent for investigational product testing is required if not already incorporated in blood
establishments standard consent form. Specific consent is required if samples for research are to be collected
and stored.
• CCP will be collected by apheresis as a licensed FFP or PF24 component. Production from whole blood can also
be considered.
• Blood collection establishments may follow their current policies for retrieval and quarantine. Refer to FDA’s
March 11th optional precautionary measures.
Convalescent Plasma Processing
• Attachment A depicts the processing pathways available. Blood collection establishments should follow existing
SOPs for collection of licensed FFP and PF24.
• CCP is an allogeneic collection for which all FDA regulations apply, including testing, processing, storage, and
traceability [Refer to the FDA’s March 24th Communication]. Convalescent plasma products should include a tie
tag making it possible to identify the unit for segregated storage of CCP inventory.
Labeling CCP as FFP or PF24 with attributes – refer to FDA’s March 24th Communication:
• Blood collection establishments will collect apheresis plasma suitable as an FFP or PF24 component and
distribute these units to hospitals.
• The hospital’s issuance of the unit to a patient for treatment of COVID-19 must be done under an established
IND pathway and may include establishing an acceptable result on a SARS-CoV-2 antibody assay to qualify the
unit for use as CCP.
• Such a CCP collection would be labeled as FFP or PF24 with appropriate attributes and cautionary statement.
The labeling of these licensed blood components must:
• Include the attribute indicating the antibody test result for the collection: “This product contains SARS-CoV-2
antibodies measured using an investigational assay” and the result may be placed on the tie tag.
• Include the cautionary statement, which may be placed on the tie tag, “Caution: New Drug--Limited by Federal
(or United States) law to investigational use.”
• ISBT Product Codes as an attribute:
o Use the appropriate ISBT product codes for convalescent plasma collections.
o These are evolving and facilities should consult the ICCBBA website, at www.iccbba.org, for current options.
Alternative Labeling of FFP or PF24 Collections as CCP units using ICCBBA codes:
Blood collection establishments may elect to label the product described above with the Convalescent Plasma
component name. Such a product would be unlicensed but could be shipped across state lines for administration under
an FDA approve IND (the IND number should appear on the tie tag). Refer to the FDA’s March 24th Communication.
Label requirements and 4x4 Label Example:
• Must include the statement “Caution: New Drug—Limited by Federal (or United States) law to investigational
use.”
• SARS-CoV-2 antibody assay results if available.
Page 3 of 603 31 2020
• Ensure FDA registration number replaced the license number and other appropriate information for interstate
shipping, if applicable.
• Remove the reference to the Circular of Information.
Separate bag codes are not currently available. When splitting COVID-19 convalescent plasma donations, use division
codes. Information for labeling plasma products can be found in the United States Industry Consensus Standard for the
Uniform Labeling of Blood and Blood Components Using ISBT 128.
Product Suitability – refer to FDA’s March 24th Communication:
• All product suitability requirements apply, and the unit may only be released to a facility with an approved IND.
• Product volume will vary and does not determine dose at time of administration.
National Product Registry:
Following production of CCP, blood establishments should register products available for national use at
www.aabb.org/covid19registry.
RESOURCES – links to:
FDA Communications:
1. Investigational COVID-19 Convalescent Plasma - Emergency INDs – March 24, 2020
2. Updated Information for Blood Establishments Regarding the Novel Coronavirus Outbreak – March 11, 2020
3. Partial list of available tests: https://www.fda.gov/medical-devices/emergency-situations-medical-
devices/emergency-use-authorizations
4. Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions – March 26, 2020
Other resources:
5. ICCBBA website: www.iccbba.org
6. United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT
128
7. Cerus website and package inserts for those electing to implement PRT
8. ADDITIONAL RESOURCES will be posted on AABB’s COVID-19 Convalescent Plasma Resources webpage as new
information becomes available.
Page 4 of 603 31 2020
ATTACHMENT A - COVID-19 Convalescent Plasma Collection Overview
Prospective donor, ≥ 14 days well without symptoms, with written documentation of BOTH positive
diagnostic assay (onset) and negative clearance assay (recovery), referred to collection facility by
clinicians (local outreach per collection facility, national outreach per blood orgs., public health
department, professional societies, HHS et al)). Prescreening with DHQ if possible.
Acceptable donor screening with DHQ, meeting
all allogeneic criteria. Males or females who are
nulliparous or anti-HLA negative
Negative NP swab with EUA cleared Positive COVID antibody at specified
molecular test if not available from
clinician
AND level with investigational assay if
available
(predonation or with donation testing)
Tubes to research repository. Donor plasmapheresis (vs. Hospitals with no
Additional donor consent and WB), including samples for local supply can use
sampling plan. COVID antibody if not FDA’s eIND link**
done predonation
Label and Distribute as licensed* FFP/PF24 OR alternative for
CCP (ISBT-128 codes in progress) with specific attribute
(antibody positive with investigational test), cautionary
statement and FDA approved IND#, or expanded access/eIND**
PRT may be performed per local policy.
Other product types may be evaluated per local policy.
List units in national inventory database Online link at AABB
Repository
Storage locally with
export availability AND/or storage/expanded
access/eIND
Distribute to transfusion service for use at hospital with FDA
approved treatment protocols with patient consent and
outcome documentation as required.
*Registered blood establishments will determine steps
necessary for distribution of CCP collected as FFP or PF24
with attributes and cautionary statement.
Page 5 of 603 31 2020
Form 1: COVID-19 Convalescent Plasma Implementation Checklist
This checklist template should be modified to reflect the center’s policies and processes.
Preparation
□ Develop overarching procedure for convalescent plasma using the guidance provided in the document and
Attachment A
□ Define product manufacturing workflow
□ ISBT code implementation
□ Product label creation
□ Staff training on new SOPs, donor eligibility, product segregation, shipping and labeling requirements, and order
management
□ Facilitate internal education for collection, manufacturing, and distribution requirements
□ Process defined for recordkeeping of all steps (donor qualification through distribution)
Donor Eligibility and Collections
□ Process defined for donor recruitment
□ Process defined for donor screening (allogeneic + additional requirements and documentation)
□ Donor consent for collection and, if applicable, investigation/research
Convalescent Plasma Processing
□ Process defined for convalescent plasma manufacturing and storage, (pathogen reduction, if performed)
□ Process defined for segregating convalescent plasma from other frozen inventory
Labeling, Release and Distribution
□ Process defined to ensure products are labeled appropriately
□ Process defined to limit distribution to hospital with IND
□ Process defined for cGMP and Quality Assurance
□ Process defined for the receipt and fulfillment of customer orders for convalescent plasma
Page 6 of 6You can also read
